Foley Balloon for Cervical Preparation Before Dilation and Evacuation

NCT06850974 | Recruiting FDA Device

• 2 other identifiers: IRB2023-00297stony brook university
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the Foley Balloon technique for cervical preparation before second trimester surgical abortion between 16 and 21 weeks estimated gestational age in combination with misoprostol to prepare the cervix before dilation and evacuation (D\&E) instead of osmotic dilators (Laminaria). Specific Aim One: Assess definitively whether using a Foley Balloon and Misoprostol is non-inferior to osmotic dilators for cervical preparation before D\&E. Specific Aim Two: Evaluate patient satisfaction with the two methods of second trimester abortion. Specific Aim Three: Evaluate provider satisfaction with the two methods of second trimester abortion.

Conditions

Abortion, Second Trimester; Abortion, Medical

Keywords

second; trimester; abortion; surgical; balloon; Foley

Outcome Measures

Primary Outcomes (1)

• Total Procedure Time (TPT)

  Determine if Foley Balloon arm (misoprostol and foley balloon) is different to Laminaria arm (Laminaria only) in changing Total Procedure Time (TPT) of dilation and evacuation (D\&E) procedure.

  through completion of D&E, approximately 15-20 minutes

Secondary Outcomes (6)

• D&E operative time (OT)

  through completion of D&E, approximately 15-20 minutes

• Initial pre-operative cervical dilation

  through completion of D&E, approximately 15-20 minutes

• Potential Complications

  through completion of the D&E, an average of 1-2 days

• Visual Analogue Pain Scale

  through completion of the D&E, an average of 1-2 days.

• Provider Satisfaction Questionnaire

  through study completion, an average of 1-2 days

Study Arms (2)

Foley Balloon and misoprostol

EXPERIMENTAL

Patients in the Foley Balloon arm will have a Foley balloon catheter placed trans-cervically and also receive misoprostol per protocol

Device: Foley Balloon Catheter; Drug: Misoprostol

Laminaria

ACTIVE COMPARATOR

Patients in the Laminaria arm will have a Laminaria placed in the cervix and it will be left in situ per protocol

Device: Laminaria

Interventions

Foley Balloon Catheter DEVICE

18 French Foley Balloon placed trans-cervically and inflated with 30-60ml of Normal Saline.

Foley Balloon and misoprostol

Misoprostol DRUG

400 mcg of buccal misoprostol sublingual

Foley Balloon and misoprostol

Laminaria DEVICE

Laminaria will be placed in the cervix according to the following standard formula: Estimated gestational age -10 = number of 5mm laminaria.

Laminaria

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients will be female confirmed pregnant patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women 18 years and older presenting to Hospital Central de Maputo requiring abortion for any legal indication between 16-21 weeks gestation.
• Portuguese speaking

You may not qualify if:

• Less than age 18
• Incarcerated
• Chorioamnionitis
• Active heavy bleeding
• A known bleeding diathesis
• Hemodynamic instability
• \> 2 cm dilation
• History of cervical cerclage
• Allergy to any study medications
• Eclampsia
• Glasgow Coma Score Less than 15

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Hospital Central De Maputo

Maputo, Mozambique

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Central Study Contacts

Sierra Washington, MD MSc

CONTACT

+258 84 147 7208; sierra.washington@stonybrookmedicine.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: the providers performing the D\&E is blinded to the cervical preparation type.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Clinical Associate Professor

Model Details: single blind randomized controlled trial

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 28, 2025
• Study Start: February 10, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 1/2026-1/2046
• Access Criteria: Independent validated investigators, peer reviewed journal editors will be able to access the study protocol, the data analysis plan and the de-identified database should they wish to perform a meta- analysis.

Locations

MO (1)